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FDA 510(k) Application Details - K080040
Device Classification Name
Diaphragm, Contraceptive (And Accessories)
More FDA Info for this Device
510(K) Number
K080040
Device Name
Diaphragm, Contraceptive (And Accessories)
Applicant
JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA.
220 RIVER ROAD
CLAREMONT, NH 03743-5647 US
Other 510(k) Applications for this Company
Contact
WILLIAM GREENROSE
Other 510(k) Applications for this Contact
Regulation Number
884.5350
More FDA Info for this Regulation Number
Classification Product Code
HDW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/2008
Decision Date
08/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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